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21 February 2025

Daily Newsletter

21 February 2025

Zealand Pharma steadfastly upholds amylin-based obesity drug strategy

Zealand’s CEO Adam Steensberg said that the company is “exactly where it wants to be” in terms of its partnering and development timeline.

Jenna Philpott February 20 2025

Zealand Pharma’s search for a partner for its amylin-based obesity therapy petrelintide remains ongoing, with no agreement announced in its 2024 earnings report.

The company has yet to secure a deal, after announcing plans to sign one with a big pharma company in August 2024. Nonetheless, CEO Adam Steensberg emphasised that Zealand is “exactly where it wants to be in the process”, on a 20 February earnings call to investors.

Steensberg went on to state that the company is focused on finding a partner with a long-term strategic vision for petrelintide’s potential role in weight management. It also aims for a co-development and co-commercialisation partnership with profit-sharing rather than a standard licensing agreement.

The delay in securing a partner comes at a time when the landscape for amylin-based therapies is mixed. Novo Nordisk’s amylin/glucagon like peptide-1 receptor agonist (GLP-1RA) combination, CagriSema (semaglutide/cagrilintide), failed to impress investors in the Phase III REDEFINE 1 trial (NCT05669755). Participants on CagriSema lost about 23% of their body weight, compared with 12% for those taking cagrilintide by itself, 16% for those on semaglutide, and 2.3% for people on a placebo. The trial met its primary endpoint but missed the mark of the 25% weight loss, which was Novo’s aim. .

Petrelintide is currently being investigated in the Phase II ZUPREME clinical trial (NCT06662539), which targets a 15% to 20% weight loss. Despite CagriSema’s results, Zealand’s chief medical officer David Kendall said that he has “great confidence” that petrelintide will meet this 15% to 20% target.

While GLP-1RAs like semaglutide work by stimulating insulin secretion, reducing glucagon levels, and slowing gastric emptying, amylin analogues such as petrelintide act through a different mechanism. By mimicking the hormone amylin, they suppress glucagon secretion, slow gastric emptying, and increase satiety. Zealand believes this distinct mode of action could position petrelintide as a best-in-class therapy in obesity and diabetes.

Zealand’s confidence in petrelintide is supported by broader investor interest in new and innovative obesity therapeutics. In June 2024, the company raised $1bn through a share offering, surpassing its original target of $900m. Earlier in January 2024, Zealand secured an additional DKr1.45bn ($204m) in funding for its obesity pipeline through a private placement and directed share issue to US investment firms. The company’s lead obesity asset, survodutide, a glucagon/GLP-1 receptor dual agonist partnered with Boehringer Ingelheim, has already advanced into Phase III trials for obesity and metabolic dysfunction-associated steatohepatitis (MASH).

Despite strong investor backing, Zealand has faced setbacks in other areas. The company’s regulatory challenges in 2024 included two US Food and Drug Administration (FDA) complete response letters (CRLs). In October, the FDA declined to approve dasiglucagon for congenital hyperinsulinism, citing the need for a reinspection of a third-party manufacturing site. In December, the agency rejected Zealand’s approval bid for glepaglutide in short bowel syndrome (SBS), recommending an additional clinical trial to establish its efficacy and safety.

Financially, Zealand reported a widened net loss of DKr1.08bn in 2024, up from DKr703.7m in 2023. The company’s operating expenses rose to DKr1.33bn from DKr895.9m , while annual revenue declined significantly to DKr62.7 from DKr342.8m . Looking ahead, Zealand expects net operating expenses to rise further in 2025, forecasting a range of DKr2bn to DKr2.5bn .

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